BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 19817344 · Received July 24, 2024

    Report

    Report Number
    2124215-2024-45822
    Event Type
    Malfunction
    Date Received
    July 24, 2024
    Date of Event
    July 13, 2024
    Report Date
    July 24, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIK
    PMA / PMN Number
    P010012/S024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH, OUT OF RANGE PACING IMPEDANCE (> 3,000 OHMS). THE (LV) LEAD PACING IMPEDANCE WAS STABLE 800-900 OHMS, UNTIL RECENTLY JUMPED TO 3,000 OHMS. AN ALERT POSTED TO THE LATITUDE WEBSITE FOR LV INTRINSIC AMPLITUDE OUT OF RANGE. A TECHNICAL SERVICE (TS) CONSULTANT WAS ASKED TO REVIEW LATITUDE WEBSITE DEVICE DATA. TS PROVIDED RECOMMENDATIONS TO PERFORM LEAD EVALUATION OF IMPEDANCE MEASUREMENTS AND NOISE, DURING THE FOLLOWING AGGRESSIVE PATIENT MANEUVERS/ISOMETRICS, POCKET MANIPULATION AND X-RAY IMAGING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME EVIDENCE SUGGESTS THE LEAD REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353825 EASYTRAK 2 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D NIK BOSTON SCIENTIFIC CORPORATION 4518

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown